BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PROXIMAL TIBIAL PL 4.5/5.0 LAT LE SH

    MDR report key: 3192326 · Received June 27, 2013

    Report

    Report Number
    3003506883-2013-00279
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    October 15, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K011978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION HAS SHOWN THAT INDEED THE RETURNED ARTICLE SHOW SOME DISCOLORATION/MARKS ON THE SURFACE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. BASED ON THESE FINDINGS WE CONCLUDE THAT WHILE THE BLACK SPOTS MAY BE RELATED TO THE CLEANING AND MAINTENANCE OF THE DEVICE, IT IS NOTED THAT THE DEVICE IS SEVERAL YEARS OLD AND THEREFORE IT CAN BE STATED THAT THE DISCOLORATION/MARKS HAVE BEEN CAUSED BY REPETITIVE STERILIZATIONS OVER THE YEARS. PLEASE NOTE: CONCERNING THE VISIBLE SIGNS OF CORROSION IT HAS TO BE POINTED OUT THAT EVEN THE SO-CALLED STAINLESS STEEL IS ONLY RUST-RESISTANT. THE CORROSION RESISTANCE IS ONLY ENSURED, WHEN THE PRODUCTS ARE STORED AT DRY CONDITIONS. IN ADDITION ALL METALLIC CONTACTS AT HUMID OR WET CONDITIONS MAY CREATE ELECTROLYTIC REACTIONS RESULTING IN CONTACT CORROSION. RUST FREE ENDURANCE IS ONLY POSSIBLE IF THE MATERIAL IS ALWAYS IMMEDIATELY DRIED AND STORED IN A DRY AREA. IN THIS REGARD IT IS ALSO NOTED TO BE AWARE OF THE GENERAL GUIDELINES FOR REPROCESSING, CARE AND MAINTENANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMALL BLACK DOTS OR RUST MARKS WAS FOUND ON THE PROXIMAL PLATES OF THE INSTRUMENT. THE PLATE HAS BEEN IN THE WASHING MACHINE SEVERAL TIMES. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294433 LCP PROXIMAL TIBIAL PL 4.5/5.0 LAT LE SH HRS SYNTHES ELMIRA 5213299

    Patients

    Seq Age Sex Outcome Treatment
    1